Posted by Ron Hill on July 2, 2010, at 3:00:52
In reply to Re: Agomelatine add-on to Nardil » Ron Hill, posted by Bob on July 2, 2010, at 1:22:46
> Wow, 6 phase III trials? It sounds like the efficacy is questionable.
I gave the wrong impression. Three of the trials clearly showed efficacy. For example, one study showed that agomelatine has as a similar antidepressant effect as the trial comparisons, Paxil and Zoloft. The other three Phase III trials were more questionable, as stated here:
http://wapedia.mobi/en/Agomelatine#1.
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Although some controlled studies in humans have shown that agomelatine is as effective as the SSRI antidepressants paroxetine and sertraline in the treatment of major depression [8] , there are unpublished randomised controlled trials which have failed to show that agomelatine is more effective than placebo [9] [9] . Agomelatine appears to cause fewer sexual side effects and discontinuation effects than sertraline and paroxetine. Additionally, possibly because of its action on melatonin receptors, agomelatine appears to improve sleep quality, with no reported daytime drowsiness [7] . Agomelatine has demonstrated anxiolytic properties [10] . Its efficacy in generalized anxiety disorder has been assessed by Stein et al (2008) who reported it significantly more effective than placebo treatment. [11]
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>I don't understand how drug after drug like this one get approved in Europe but then don't make it to approval over here.It was difficult to get it approved in the EU as well:
http://wapedia.mobi/en/Agomelatine
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Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd. Servier continued to develop the drug and conduct phase III trials in the European Union. In March 2005 Servier submitted agomelatine to the European Medicines Agency (EMEA) under the trade names Valdoxan and Thymanax. [12] On 27 July 2006 the Committee for Medical Products for Human Use (CHMP) of the EMEA recommended a refusal of the marketing authorisation of Valdoxan/Thymanax (agomelatine). The major concern was that efficacy had not been sufficiently shown. The CHMP had no special concerns about the side effects. [12] In September 2007, Servier submitted a new marketing application for Valdoxan (agomelatine) to the EMEA. [13] On 20 November 2008, Valdoxan was given a positive opinion, with restrictions, [14] by the EMEA [13] , and was subsequently given marketing authorisation in the European Union on 20 February 2009. [15] Release dates for agomelatine will depend on marketing arrangements in the individual countries of the EU.
In March 2006, Servier announced it had sold the rights to market agomelatine in the United States to Novartis. [16] Agomelatine is currently undergoing phase III clinical trials in the US. [17]
Novartis currently lists the drug as scheduled for submission to the FDA no earlier than 2012.
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I feel sure agomelatine will be approved in the U.S.
Keep in mind that I am interested in agomelatine for its potential treatment of circadian rhythm problems in hopes that it will reduce the severity of my bipolar II ultra rapid cycling (15 day cycle; 9 days in full remission and 6 days in debilitating depression. The 15 day cycle repeats over and over and ... without end).
Nardil is my heavy-hitter antidepressant, and I must keep it on board. The puny amount of antidepressant effect that I expect to be contributed by agomelatine will be just gravy on my Nardil meat and potatoes.
> I wasn't aware that a 3-month supply could be obtained from my doctor like that. Thanks for the info.
You bet.
-- Ron
poster:Ron Hill
thread:952388
URL: http://www.dr-bob.org/babble/20100628/msgs/952927.html